Senior Component Engineer, Medical Devices & Compliance

Diality, Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance across development and manufacturing, ensuring supply continuity and regulatory compliance in a medical device setting.

You will partner with Engineering, Quality, and Supply Chain to manage lifecycle risks, review PCNs, and qualify alternate sources, while driving cost optimization and data integrity in PLM/ERP systems. This role emphasizes cross-functional collaboration, risk mitigation, and sustaining a robust

Qualifications

• Experience working in a regulated medical device environment.
• Ability to assess supply chain risks and mitigation strategies.
• Strong communication and cross-functional collaboration.
• Familiarity with PLM/ERP systems.

Responsibilities

• Partner with Engineering to ensure component selections meet performance and supply continuity.
• Monitor lifecycle status and mitigate obsolescence.
• Support ECOs for additions, substitutions, and PCNs.
• Ensure RoHS/REACH compliance and audit readiness.
• Collaborate across Engineering, Quality, Manufacturing, and Supply Chain.

Skills

Regulatory compliance understanding

Analytical thinking

Project coordination

Independent work

Education

Bachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field

Tools

Propel

NetSuite

Job description

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance across development and manufacturing, ensuring supply continuity and regulatory compliance in a medical device setting.

You will partner with Engineering, Quality, and Supply Chain to manage lifecycle risks, review PCNs, and qualify alternate sources, while driving cost optimization and data integrity in PLM/ERP systems. This role emphasizes cross-functional collaboration, risk mitigation, and sustaining a robust